Medical Device Recalls

DeRoyal FACIAL PACK PGYBK, REF 89-10007.03

DeRoyal Industries Inc

Dewei DNA/RNA Preservation Kit, Catalog number DW-80005-1B

DEWEI MEDICAL EQUIPMENT CO LTD

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, Medline Kit Number/

Medline Industries, LP

Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) adm

B. Braun Medical, Inc.

QIAstat-Dx¿ Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-C

Qiagen GmbH

Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L

Medline Industries, LP

DeRoyal CATARACT PACK CSM, REF 89-6863

DeRoyal Industries Inc

ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4

Getinge Usa Sales Inc

COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator

Medtronic Inc.

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Steris Corporation

Product Desc: Product Name: A-OK 19G V-LANCE FULL HANDLE1.6MM SATIN Model/Catalog Number: 8065911901 Software Version:

Alcon Research LLC

STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,

Stradis Medical, LLC dba Stradis Healthcare

ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor

Siemens Medical Solutions USA, Inc

Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100

Howmedica Osteonics Corp.

LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631

Howmedica Osteonics Corp.

Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

Philips North America Llc

KARL STORZ - ENDOSKOPE, REF: 27003L, MICHEL Uretero-Renoscope, 9.5 Fr., 43cm, RxONLY, CE0123

Karl Storz Endoscopy

Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph

Baxter Healthcare Corporation

Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 1.0.0.951, 11.0

RAYSEARCH LABORATORIES AB

Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY

Merit Medical Systems, Inc.

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

Aesculap Implant Systems LLC

BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and

Becton Dickinson & Co.

Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified p

Remote Diagnostic Technologies Ltd.

Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay fo

DRG International, Inc.

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella C

Abiomed, Inc.

Infusomat utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space L

B Braun Medical Inc

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommen

ev3 Inc.

MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672

MEDLINE INDUSTRIES, LP - Northfield

HAMILTON T1 Ventilator REF 161006 1610060 161009 1610090 Is intended to provide positive pressure ventilatory sup

Hamilton Medical, Inc.

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Philips North America